Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
This study has been completed.
Sponsor:
Graceway Pharmaceuticals, LLC
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00189306
First received: September 13, 2005
Last updated: August 5, 2010
Last verified: August 2010
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Purpose
An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.
| Condition | Intervention | Phase |
|---|---|---|
|
Superficial Basal Cell Carcinoma |
Drug: Imiquimod 5% cream |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Graceway Pharmaceuticals, LLC:
Primary Outcome Measures:
- Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
Secondary Outcome Measures:
- Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks [ Time Frame: 12 week posttreatment visit ] [ Designated as safety issue: No ]Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)
| Enrollment: | 169 |
| Study Start Date: | March 2001 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aldara
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
|
Drug: Imiquimod 5% cream
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Other Name: Aldara (imiquimod) 5% cream - 250 mg / packet
|
Detailed Description:
Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have at least 1 previously untreated superficial basal cell carcinoma tumor
- Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm
Exclusion Criteria:
- Evidence of clinically significant, unstable medical conditions
- Cannot have recent use of topical steroids or retinoids in the treatment area.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189306
Locations
| Australia, New South Wales | |
| Medical Centre, Concord Hospital | |
| Concord, New South Wales, Australia | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia | |
| Australia, Queensland | |
| Skin Centre | |
| Benowa, Queensland, Australia | |
| South East Dermatology Centre | |
| Carina Heights, Queensland, Australia | |
| 105 Fulham Road | |
| Gulliver, Queensland, Australia | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia | |
| Australia, South Australia | |
| Flinders Medical Center | |
| Bedford Park, South Australia, Australia | |
| Queen Elizabeth Hospital | |
| Woodville, South Australia, Australia | |
| Australia, Victoria | |
| Western Hospital | |
| Footscray, Victoria, Australia | |
| Austin & Repartriation Hospital | |
| Heidelburg, Victoria, Australia | |
| Australia, Western Australia | |
| Freemantle Dermatology | |
| Fremantle, Western Australia, Australia | |
| 158 South Terrace | |
| Perth, Western Australia, Australia | |
| Subiaco Clinic | |
| Subiaco, Western Australia, Australia | |
| New Zealand | |
| 103A Mountain Road | |
| Epsom, Auckland, New Zealand | |
| Birthcare Building | |
| Parnell, Auckland, New Zealand | |
| Dermatology Practice | |
| Christchurch, New Zealand | |
| Colombo Mansions | |
| Christchurch, New Zealand | |
| Skin Institute Limited | |
| Takapuna, New Zealand | |
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
| Study Director: | Jim Lee, Dr. | Graceway Pharmaceuticals |
More Information
Publications:
| Responsible Party: | Medical Director, Graceway Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00189306 History of Changes |
| Other Study ID Numbers: | 1413-IMIQ |
| Study First Received: | September 13, 2005 |
| Results First Received: | October 30, 2008 |
| Last Updated: | August 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Graceway Pharmaceuticals, LLC:
|
Superficial Basal Cell Carcinoma Aldara |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Imiquimod |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on June 17, 2013